Women with hypoactive sexual desire disorder (HSDD) report that flibanserin increased their sexual desire and reduced associated distress

Ingelheim, Germany, 19 May 2010, 08:00 CET – Significantly more pre-menopausal women with hypoactive sexual desire disorder (HSDD) reported a clinically meaningful improvement in their condition with flibanserin 100mg compared with placebo, according to new research announced today.¹ Flibanserin is an investigational, non-hormonal treatment being developed by Boehringer Ingelheim for pre-menopausal women with HSDD.

More than 1,300 women were included in the pre-specified, pooled Phase III study analysis, presented at The American Congress of Obstetricians and Gynaecologists (ACOG) annual clinical meeting. All of the women had HSDD – a medical condition characterised by a decrease in sexual desire associated with marked distress and/or interpersonal difficulties.²

“We know that flibanserin is effective and well tolerated in a clinical setting, but it’s important to understand too whether patients themselves see a benefit from treatment,” said John Thorp, study investigator and Professor of Obstetrics and Gynaecology at the University of North Carolina Medical School. “These study results are very encouraging – not only did women report an improvement in their HSDD symptoms, but they felt the improvement was meaningful to them and their overall well-being.”

The patients’ perspective analysis builds on existing Phase III clinical trial data which demonstrate that flibanserin 100mg taken once daily at bedtime significantly increased sexual desire while significantly decreasing the distress associated with HSDD.³ This was reflected in a significant increase in the number of Satisfying Sexual Events (SSEs)

Study participants evaluated their treatment based on two measures – overall improvement in their condition, and the question “Do you believe you experienced a meaningful benefit from the study medication?”

Of 1,338 participants questioned (flibanserin=659, placebo=679):

• over 50% more women reported feeling ‘very much improved’, ‘much improved’ or ‘minimally improved’ with flibanserin compared with placebo (318 vs. 206, p<0.0001)

Of 1,219 participants questioned (flibanserin=593, placebo=626):

• over 50% more women reported a meaningful benefit from treatment with flibanserin compared with placebo (240 vs. 158, p<0.0001).

A second pre-specified analysis of the phase III study data presented at the meeting looked specifically at women who completed treatment to trial end.

Those who received flibanserin 100mg vs. placebo experienced statistically significantly:*

• increased sexual desire, based on improvements in:
  - e-diary sexual desire score (9.7 vs. 6.9, p<0.01)
  - FSFI desire domain score (0.9 vs. 0.5, p<0.0001)
• reduced associated distress, based on improvements in:
  - FSDS-R Item 13 score (-0.8 vs. -0.5, p<0.0001)
  - FSDS-R total score (-9.3 vs. -5.0, p<0.0001)
• more satisfying sexual events (2.1 vs. 0.9, p<0.0001)
• improved overall sexual functioning, based on improvements in:
  - FSFI total score (5.3 vs. 2.6, p<0.0001)

“Although HSDD affects thousands of women, it is often misunderstood or overlooked,” said Paula Hall, a sexual and relationship psychotherapist from the UK. “In both of these study analyses, we’re seeing very positive outcomes with flibanserin, which is really quite exciting and could hold hope for those suffering with this distressing condition.”

About the studies

In both studies, data from two 24-week randomised, placebo-controlled Phase III North American trials (VIOLET® and DAISY®) were pooled in a pre-specified analysis.

1. Patient perspectives on flibanserin treatment ¹

In the first analysis, study participants were asked to:

• evaluate the overall improvement in their condition (bothersome decreased sexual desire) using the Patient’s Global Impression of Improvement (PGI-I) measure, which is rated on a 7-point scale from 1 (very much improved) through 4 (no change) to 7 (very much worse)
• evaluate whether they experienced a meaningful benefit from study medication at study end using the single-question Patient Benefit Evaluation – “Overall, do you believe that you have experienced a meaningful benefit from the study medication?”

2. Analysis of women who completed treatment to study end ⁴
The second analysis specifically evaluated those women who completed 24 weeks’ treatment (n=971, 70.5%). Co-primary endpoints were change from baseline to study end in the number of satisfying sexual events (SSE) and sexual desire score measured using a daily electronic diary (eDiary).

• Sexually satisfying events (SSE) measures the number of sexual events (defined as sexual intercourse, oral sex, masturbation or genital stimulation by the partner), and whether the event was satisfying for the woman (i.e. gratifying, fulfilling, satisfactory and/or successful), irrespective of whether women had an orgasm or whether the event was satisfying for the partner.
• The eDiary measures levels of desire on a daily basis, with the help of a proprietary electronic device. Levels of desire to choose from were “no” “low” “moderate” or “strong” desire.

Secondary endpoints included change in Female Sexual Function Index (FSFI) desire domain, FSFI total, Female Sexual Distress Scale-Revised (FSDS-R) Item 13 and FSDS-R total scores.

• The FSFI is a 19-item questionnaire which provides an additional measurement of changes over a longer recall period. The tool, which has a specific desire domain, assesses both the intensity and the frequency of desire over a 4-week period.
• The FSDS-R is a 13-item questionnaire designed to assess and quantify the change in personal distress associated with female sexual dysfunction. Question 13 specifically assesses distress due to low sexual desire. The total score ranges from 0-52, with higher scores indicating more sexual distress.

The majority of these tools have been independently developed. All measures have undergone rigorous testing to ensure they are valid and reliable.

About flibanserin

Boehringer Ingelheim is investigating flibanserin as a novel, non-hormonal treatment for premenopausal women with HSDD. Flibanserin 100mg, taken once daily orally has been proven effective and well-tolerated in phase III clinical trials in these women suffering from HSDD.³ The intended brand name for flibanserin is Girosa®.

How does flibanserin work?
Flibanserin is a 5-HT1A agonist and 5-HT2A antagonist. The term refers to the fact that flibanserin mainly targets these two types of serotonin receptors, the 5-HT1A receptor as an agonist and the 5-HT2A receptor as an antagonist. Preclinical evidence shows that flibanserin targets these receptors preferentially in selective brain areas. An intricate interplay between stimulatory neurotransmitter systems (dopamine and norepinephrine) and inhibitory systems (serotonin, 5-HT) is part of the natural sexual response. By modulating these neurotransmitter systems in selective brain areas, flibanserin may correct an imbalance in these systems, which leads to a healthy sexual response.⁵

About Hypoactive Sexual Desire Disorder

HSDD is a form of Female Sexual Dysfunction (FSD). As defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV), HSDD is the persistent lack (or absence) of sexual fantasies or desire for any form of sexual activity marked by distress or interpersonal difficulty and not better accounted for by another disorder (except another sexual dysfunction), direct physiological effects of a substance (including medications) or a general medical condition. Generalised, acquired HSDD is not limited to certain types of stimulation, situations or partners, and develops only after a period of normal functioning.² Low sexual desire with associated distress is the most commonly reported female sexual complaint. In prevalence studies⁶ approximately 1 in 10 women reported low sexual desire with associated distress, which may be HSDD. Sexual Desire Disorders are generally under-diagnosed and there are currently no pharmacological treatments available for pre-menopausal women with HSDD. HSDD has been recognised as a medical condition for over 30 years.

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Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

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